FENISTIL COLD SORE

Adults (including older people) and children over 12 years of age Fenistil Cold Sore Cream should be applied at approximately two hourly intervals during waking hours, (approximately 8 times a day). Treatment should be continued for 4 days.

If the condition gets worse or does not improve after 4 days treatment, seek medical advice. Treatment should be started as early as possible after the first sign of an infection.

Paediatric population Children (under 12 years):

The safety and efficacy of Fenistil Cold Sore Cream in children below 12 years of age have not been established. No data are available.

Summary of the safety profile Fenistil Cold Sore Cream has been well-tolerated in human studies. Clinical trial experience has shown that there was no difference between Fenistil Cold Sore Cream and placebo in the rate or type of adverse reactions reported.

The most common events are application site adverse events. Tabulated list of adverse reactions Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); unknown (cannot be estimated from available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

General disorders and administration site condition:

Common application site reactions (including skin burning sensation, pain of skin, hypoaesthesia) Post-marketing surveillance has revealed the following adverse events (all reactions were either localised or generalised). Adverse events from post- marketing experience are difficult to calculate a frequency and therefore the events are listed as unknown frequency.

Immune System disorders:

Not known hypersensitivity, urticarial Skin and subcutaneous disorders: dermatitis allergic (including rash, pruritus, Not known blisters and oedema) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

The cream should only be used on cold sores on the lips and around the mouth. g. in the eyes, mouth, or nose or on the genitals). Particular care should be taken to avoid application in or near the eyes. Patient with particularly severe cold sores should be encouraged to seek medical advice.

Patients should be advised to avoid transmitting the virus, particularly when active lesions are present. g. AIDs patients or bone marrow transplant recipients) should be encouraged to consult a physician in case oral therapy is indicated.

g. contact dermatitis). It also contains propylene glycol, which may cause skin irritation.

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